MAUDE Adverse Event Report: KINAMED, INC. CARBOJET BONE LAVAGE SYSTEM; LAVAGE, JET

Catalog Number 25-200-0220

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 07/07/2015

Event Type  Injury  

Event Description

The sales representative reported a total shoulder arthroplasty case in which the patient experienced reduced blood pressure and decreased oxygen saturation while the last glenoid component peg hole was being cleaned with the carbojet system (using the angled tip nozzle).A gas embolism was the suspected cause.The anesthesiology team spent about 5 minutes administering a drug(s) and watching the patient until the vital signs returned to normal levels.The remainder of the case was completed uneventfully.The senior operating surgeon reported that the patient was doing ok post-operatively and was kept overnight in the icu for observation.At the time of the event, the surgical fellow had fully inserted the tip of the nozzle to the bottom of the last glenoid peg-hole.The senior surgeon is very experienced with the carbojet system and stated that he himself does not insert this nozzle to the bottom of the peg hole but instead holds the nozzle tip just over the opening of the peg-hole.

Manufacturer Narrative

The carbojet system has been used in over 100,000 clinical cases since 1993; the vast majority of uses are in arthroplasty of the shoulder, knee, and hip.The system was invented by a shoulder arthroplasty surgeon and has a long history of successful use in shoulder arthroplasty without adverse events.This is the first report from the field of this type and the complaint rate based on usage is extremely low.There is an interosseous vein that travels down the middle of the glenoid vault which is familiar to shoulder arthroplasty surgeons because it routinely experiences inadvertent damage when drilling fixation holes into the glenoid (for fixation of the arthroplasty implant).Based on discussions with the reporting senior surgeon as well as another experienced shoulder arthroplasty surgeon, the root cause of this event is most likely due to compromise of the interosseous vein while drilling the glenoid peg holes followed by full insertion of the co2 (carbon dioxide gas) delivery nozzle into the depth of the peg hole.A compromised vein could allow ingress of co2 or another gas directly into the venous circulation.A literature review performed immediately after the initial report found that venous air embolism (vae) and co2 embolism are rare but known complications during surgeries that utilize gas insufflation and during orthopedic procedures where the surgical site is above the heart (e.G.Shoulder arthroplasty).The incidence of carbon dioxide embolism during laparoscopic procedures is reported to be 0.00442% based on a review of 6 studies involving 769,239 patients.When under pressure, gas can migrate through a fracture and into the venous system causing vae or a vein can be inadvertently punctured allowing for a direct pathway of gas into the venous system, blocking the right ventricle or pulmonary artery.Because of such risks, it has been widely acknowledged for decades that carbon dioxide gas is the preferred media for insufflation and other internal procedures involving medical gas because co2 is 5 times less toxic than air, is 46 times more soluble in blood than nitrogen, and is 25 times more soluble in blood than oxygen (nitrogen and oxygen being the primary constituents of air).In summary, co2 embolism is a rare but known complication in surgery involving carbon dioxide gas.During a subsequent literature review on 08/04/2015, a similar adverse event (occurring in spain) involving carbojet was found in a case report that was published in 2012 in a spanish-language anesthesiology journal.The case report involved an (b)(6) patient who experienced cardiorespiratory arrest during cemented hip hemiarthroplasty and required cardiopulmonary resuscitation.This complication was reported to have occurred immediately after using the carbojet and was attributed to gas embolism once other entities were ruled out.This literature finding will be reported and investigated as a separate incident.It was also found that the same case (same patient, same hospital) was redundantly published in 2014 in a spanish-language orthopedic journal.Review of the carbojet system ifu confirms the appropriate precautions are contained in relation to the intended use, based on a long history of safe usage for the cleared indications.As an added precaution, the ifu warnings will be revised to address the occurrence of potential carbon dioxide gas embolism.The device was not returned for evaluation and the exact lot numbers involved in the event were not reported.Review of device history records for recently supplied pressure regulators, tube sets, handpieces and angled nozzles show they were released with no deviations or non-conformances.Device not returned.

Event Description

On (b)(6) 2015 the senior surgeon reported, the patient was transferred out of the icu after overnight observation and discharged from the hospital three nights after surgery without any sequelae.The senior surgeon has seen the patient for multiple follow-up visits in his office and he/she does not have any post-op health problems pertaining to this event.

• Brand Name: CARBOJET BONE LAVAGE SYSTEM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): KINAMED, INC.; 820 flynn road; camarillo CA 93012 8701
• Manufacturer (Section G): KINAMED, INC.; 820 flynn road; camarillo CA 93012 8701
• Manufacturer Contact: heather neely ; 820 flynn road; camarillo, CA 93012-8701 ; 8053842748
• MDR Report Key: 4975801
• MDR Text Key: 17201701
• Report Number: 2027148-2015-00002
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 25-200-0220
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: (B)(4) CARBOJET PRESSURE REGULATOR; (B)(4) CARBOJET CO2 TUBE SET (SINGLE USE); (B)(4) CARBOJET HANDPIECE
• Patient Outcome(s): Hospitalization; Required Intervention